Mock sheets and lack of stability data: US FDA hits two API makers with warnings

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The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.

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Drugs tracked in Ongar: Selcia opens radiolabelled API plant

Dhanuka Laboratories facility in Gurgaon

Croatia's Halmed finds GMP deficiencies at Dhanuka Labs' antibiotic API plant

Colorcon to buy BASF's Kollicoat coating system product

Colorcon to buy BASF's Kollicoat coating system product

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Combination therapies key to curing cancer, says Pfizer

Recipharm offers free serialization (iStock/3D_generator)

Recipharm will serialize customers' drugs for free until US and EU rules come into force

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Biotrial criticised over fatal Phase I study by France's social affairs inspectorate

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Regulatory & Safety

Peel-ID seeks to reduce a patient’s risk of receiving the incorrect medication at clinical sites. (Image: iStock/Kwangmoozaa)

Catalent launches new kit labeling system to reduce 'risk of human error'

James Lind  (4 October 1716 – 13 July 1794) - wikipedia

Clinical Trials Day: focusing on awareness, the ‘war on talent,’ and an industry-wide commitment

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MPA withdraws Bend's Oregon plant GMP certificate citing deficiencies

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Ingredients

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IMA: Angina drug API firm JP Laboratories cannot keep Daund plant up to code

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Italian regulator slams simvastatin-maker Krebs for GMP deviations

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Olon SpA to buy Infa Group

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Drug Delivery

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Albumedix tech key to Chinese efforts to develop once-a-week diabetes drug

Drug particles, minus excess surfactant, suspended in an injectable solution. (Image: Jonathan Lovell, University at Buffalo)

New technique creates 'nearly pure drug' for injection

André René Roussimoff (May 19, 1946 – January 27, 1993) a wrestler known as André the Giant suffered from acromegaly. (source Flickr/ John McKeon)

Glide begins solid dose, injectable acromegaly drug trial on birthday of most famous sufferer

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Processing

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Juniper invests in mixer tech for UK plant

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Glatt and Innopharma target India with integrated PAT offering

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Endo takes axe to Par manufacting network: 740 jobs affected

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Popular News

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MPA withdraws Bend's Oregon plant GMP certificate citing deficiencies

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Concealed compliance info lands ex-Ranbaxy owners $385m costs

André René Roussimoff (May 19, 1946 – January 27, 1993) a wrestler known as André the Giant suffered from acromegaly. (source Flickr/ John McKeon)

Glide begins solid dose, injectable acromegaly drug trial on birthday of most famous sufferer

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